: Identification of Non-alcoholic Steato-hepatitis Cases in a Sample of Type 2 Diabetes Patients, with a Disruption of the Liver Function Tests, At the Pointe-à-Pitre University Hospital (STEATOGWAD)

Identification of Non-alcoholic Steato-hepatitis Cases in a Sample of Type 2 Diabetes Patients, with a Disruption of the Liver Function Tests, At the Pointe-à-Pitre University Hospital

Non-alcoholic steatohepatitis (NASH) develops on insulin resistance, especially in patients with carbohydrate tolerance. NASH may progress to more extensive fibrosis, including cirrhosis, but also to HCC with or without cirrhosis in 10 to 20% of cases. The main objective of our research is to identify the prevalence of NASH in a sample of 100 patients with type 2 diabetes mellitus (T2DM), consulting in the PAP hospital and having a liver function disorder

Study Overview

• Status: Completed
• Conditions: Non-alcoholic Steato-hepatitis
• Intervention / Treatment: Diagnostic test: Fibrotest-actitest/NASHtest

Detailed Description

In Guadeloupe, the prevalence of T2DM is estimated to be 20%, among the highest in the French departements. NASH is probably present in our patients with T2DM but we do not know its prevalence. There is no data on the development of NASH in the Afro-Caribbean population, but in the United States, it has been observed that NASH was less prevalent among African-Americans compared to Caucasian and Hispanic Americans, and this could be explained by differences genetics in fat metabolism. In view of the emergence of NASH worldwide as a cause of chronic liver disease, it is necessary to carry out a pilot study to determine the presence or absence of NASH in T2DM patients in Guadeloupe. This will necessitate a systematic evaluation of liver function, usually performed during the T2DM assessment but not necessarily followed by specialized advice to confirm or invalidate the diagnosis of NASH. For each patient, an abnormality of liver function will be assessed by usual serum tests (transaminases, GGT, PAL). Prescription for a fibrotest / actitest + NASHtest and the NAFLD fibrosis score, will be perfomred as well as ultrasound and blood tests to eliminate other causes of liver disease (viral B or C, alcoholic, autoimmune, hemochromatosis) will also be performed.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Guadeloupe
  • Pointe-à-Pitre, Guadeloupe, 97159
    • CHU de la Guadeloupe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Type 2 diabetes mellitus patient with impaired hepatic function (transaminases and / or PAL and / or gamma-GT> Norm)
• Age ≥18 years
• Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
• Affiliate or beneficiary of a social security scheme.

Exclusion Criteria:

• Pregnancy or breast-feeding
• No diabetes or type 1 diabetes
• Chronic hepatopathy of other origin: viral B, C, alcohol, hemochromatosis, α1-antitrypsin deficiency, Wilson's disease, autoimmune hepatitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: type 2 diabetes with a hepatic check-up patients; For the study, a blood sample will be collected from the patient in order to do Fibrotest-actitest/NASHtest.	Diagnostic test: Fibrotest-actitest/NASHtest; A blood sample will be collected from the patient in order to do Fibrotest-actitest/NASHtest and to calculate the NAFLD fibrosis score; Other Names: NAFLD fibrosis score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fibrotest-Actitest	Fibrotest-actitest uses the biological analysis of alpha 2 macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, gGT, ALAT, ASAT, fasting blood glucose, cholesterol, triglycerides. A fibrotest score >0.48 is suggestive of advanced liver fibrosis.	24 hours
NASH test	NASHtest uses the biological analysis of alpha 2 macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, gGT, ALAT, ASAT, fasting blood glucose, cholesterol, triglycerides. NASHtest interpretation: NashTest 2 score Grade Interpretation 0.00-0.25* N0 No NASH 0.25-0.50* N1 Mild NASH 0.50-0.75* N2 Moderate NASH 0.75-1.00* N3 Severe NASH	24 hours
NAFDL fibrosis score	Non-Alcoholic Fatty Liver Disease (NAFLD) fibrosis score estimates amount of scarring in the liver based on age and body mass index of the patient, and several laboratory tests as ASAT, ALAT, platelet count and albumin. NAFLD fibrosis score can be interpretate as below: less than -1.455: low probability of fibrosis; from -1.445 to 0.676 : intermediate score; more than 0.676: high probability of fibrosis	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
: hepatic ultrasound,	Patients will be assessed by liver ultrasound which is a non invasive test that produces images of liver and its blood vessels. It's a valuable diagnostic tool for assessing liver anatomy, size and pathology as cirrhosis or liver steatosis.	24 hours
Standard liver test	Blood analysis for liver function assessment (ASAT, ALAT, gGT, PAL)	24 hours
Lipid balance	Blood analysis for lipid metabolism assessment (total cholesterol, HDL cholesterol, triglycerides), which constitutes an important risk factor for cardiovascular disease	24 hours
Lipid balance	HDL	24 hours
Lipid balance	triglyceride	24 hours
Assessment to eliminate other causes of chronic disease	HBV and HCV serologies for viral hepatitis	24 hours
Assessment to eliminate other causes of chronic disease	auto-immune antibodies for auto-immune hepatitis	24 hours
Assessment to eliminate other causes of chronic disease	ferritinemia and saturation coefficient of transferin for hemochromatosis	24 hours
Assessment to eliminate other causes of chronic disease	carboxy deficient transferin for alcoholism	24 hours
Platelets	Platelet	24 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Guadeloupe

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: type 2 diabetes mellitus; NASH,
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis A; Hepatitis; Diabetes Mellitus, Type 2; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: PAP_RI2_2017/06; 2017-A01101-52 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Any plan has been do

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No